Phase 2
Completed N=174
Dose-Finding Trial With Sugammadex Administered at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Participants of ASA Class 1-3 (P05944; MK-8616-024)
Anesthesia, General
Source: ClinicalTrials.gov NCT00535743 ↗
Enrolled (actual)
174
Serious AEs
6.9%
Results posted
Feb 2019
Primary outcomePrimary: Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 — 108.43; 44.73; 6.93; 2.40 minutes
Summary
The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic disease), or class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 |
108.43; 44.73; 6.93; 2.40; 2.42; 1.77 | — |
| SECONDARY Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 |
98.23; 40.00; 5.90; 1.87; 1.57; 1.43 | — |
| SECONDARY Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 |
91.58; 36.43; 4.55; 1.58; 1.13; 1.27 | — |
| SECONDARY Number of Participants Experiencing an Adverse Event |
5; 5; 7; 7; 8; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Participants of ASA class 1 - 3, above or equal to the age of 18 years;
- Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 120 minutes, without further need for muscle relaxation other than for intubation;
- Participants scheduled for surgical procedures in supine position;
- Participants who had given written informed consent.
Exclusion Criteria
- Participants in whom a difficult intubation because of anatomical malformations was expected;
- Participants known or suspected to have neuromuscular disorders impairing neuromuscular blocking and/or significant renal dysfunction;
- Participants known or suspected to have a (family) history of malignant hyperthermia;
- Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
- Participants receiving medication known to interfere with neuromuscular blocking agents, such as anticonvulsants and Mg^2+;
- Participants who had already participated in this trial;
- Participants who had participated in another clinical trial, not pre-approved by the Sponsor, within 30 days of entering into this trial;
- Female participants who were pregnant: in females, pregnancy was to be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who were not of childbearing potential, i.e. at least 2 years menopausal or who had undergone tubal ligation or an hysterectomy;
- Female participants of childbearing potential not using any of the following methods of birth control (for one month): condom or diaphragm with spermicide, vasectomized partner (>6 months), intrauterine device (IUD), abstinence;
- Female participants who were breast-feeding.
Data sourced from ClinicalTrials.gov (NCT00535743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.